National Cancer Institute (NCI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Diabetes and Digestive and Kidney
Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Nursing Research (NINR)
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)

Special Note: Applicants are cautioned that not all
NIH Institutes and Centers (ICs) participate in this program, and that
consultation with relevant IC staff prior to submission of an application is
strongly encouraged. The participating ICs have different emphases and
program requirements for this program. Therefore, a prospective applicant is
urged to consult the Table of
IC-Specific Information, Requirements and Staff Contacts to
determine whether the planned research and training falls within the mission
of one of the participating NIH ICs.

January 19, 2012 - See Notice NOT-MH-12-013 Notice of Revised NIMH Policies for Applications Submitted, beginning with applications due on June 12, 2012 and thereafter, NIMH will follow a revised policy regarding "renewal" (Type 2) applications.

December 14, 2011 - See Notice NOT-DA-12-005. Notice to Change Locus of Review for NIDA’s Career Development (K) Award Applications.

May 16, 2011 - See Notice NOT-AT-11-003 Notification of NCCAM Use of the NIH Parent K24 Midcareer Investigator Award in Patient-Oriented Research Partnership with the Clinical and Translational Science Institutions Consortium (K24).

April 8, 2011 – Per NOT-OD-11-063, AIDS and AIDS-related applications intended for the May 7, 2011 due date should continue to use the previously issued Parent announcements. Applications intended for June 12, 2011 and subsequent due dates must use the re-issued Parent announcements. See the Parent Announcements page for appropriate links.

The purpose of the NIH Midcareer Investigator Award in
Patient-Oriented Research (K24) is to provide support to mid-career
health-professional doctorates or equivalent who are typically at the
Associate Professor level or the equivalent (see Section III. Eligible
Individuals) for protected time to devote to patient-oriented research (POR)
and to act as research mentors primarily for clinical residents, clinical
fellows and/or junior clinical faculty. Prospective candidates are encouraged
to contact the relevant NIH staff for IC-specific programmatic and budgetary
information: Table of
IC-Specific Information, Requirements and Staff Contacts.

Key Dates

Posted Date

April 8,
2011

Open Date (Earliest Submission Date)

May 12, 2011

Letter of Intent Due Date

Not Applicable

Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Standard
dates apply, by 5:00 PM local time of applicant organization..

The NIH Midcareer Investigator Award in Patient-Oriented
Research (K24) award is designed to enable mid-career clinician scientists to:

Devote more time to augment their capabilities in
Patient-Oriented Research (POR); and

Provide mentoring to new clinical investigators in the conduct of
POR (see below for definition).

The K24 award is intended to provide protected time to
mid-career clinical investigators who are typically at the Associate Professor
level or the equivalent (see Section III, Eligible Individuals) and who have
their own independent peer-reviewed research support to provide mentoring to
junior clinical investigators, particularly K23 grantees, in POR and to
stabilize the careers of these investigators so that they could continue to
conduct POR and be available as mentors in POR. A K24 award recipient who
continues to have an independent peer-reviewed patient-oriented research
program and continues to provide mentoring to new investigators can continue to
contribute to the overall goals of the program after being promoted to Full Professor.
This award has formed an important part of the NIH initiative to attract and
retain talented individuals to the challenges of patient-oriented research. The
overall goal is to increase the pool of clinical researchers who can conduct
patient-oriented research, who will be able to successfully compete for
peer-reviewed grants, and who will mentor the next generation of clinical
investigators.

It is expected that K24 recipients will obtain new or
additional independent peer-reviewed funding for POR as PD/PI and establish and
assume leadership roles in collaborative POR programs. In addition, it is
expected that there will be an increased effort and commitment to act as a
mentor to beginning clinician investigators in POR to enhance the research
productivity of both the K24 investigator and increase the pool of well-trained
clinical researchers of the future.

For the purposes of this award, Patient-Oriented Research is
defined as research conducted with human subjects (or on material of human
origin such as tissues, specimens and cognitive phenomena) for which an
investigator directly interacts with human subjects. This area of research
includes: 1) mechanisms of human disease; 2) therapeutic interventions; 3)
clinical trials; and 4) the development of new technologies. Studies falling
under Exemption 4 for human subjects research are not included in this
definition. See also the NIH
Directors Panel on Clinical Research Report.

Special Note: Applicants are cautioned that not all
NIH Institutes and Centers (ICs) participate in this program, and that
consultation with relevant IC staff prior to submission of an application is
strongly encouraged. The participating ICs have different emphases and program
requirements for this program. Therefore, a prospective applicant is urged to
consult the Table of IC-Specific Information, Requirements and
Staff Contacts to determine whether the planned research and
training falls within the mission of one of the participating NIH ICs.

Section II. Award
Information

Funding Instrument

Grant

Application
Types Allowed

New
Resubmission
Renewal
Revision

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH
appropriations, and the submission of a sufficient number of meritorious
applications..

Award Budget

Award budgets are composed of salary and other
program-related expenses, as described below.

Award Project Period

The total project period may not exceed 5 years.

Other Award Budget
Information

Salary

The NIH Midcareer Investigator
Award in Patient-Oriented Research (K24) will provide salary for levels of
effort between 3-6 person-months (or 25 and 50% full-time professional effort).
The actual salary provided by the award is based on a full-time, 12-month
staff appointment at the sponsoring institution, the PD/PIs institutional
salary, and the level of effort requested, up to the maximum legislated
salary rate in effect at the time of award (see: http://grants.nih.gov/grants/policy/salcap_summary.htm).

The salary must be consistent
both with the established salary structure at the institution and with salaries
actually provided by the institution from its own funds to other staff
members of equivalent qualifications, rank, and responsibilities in the
department concerned. If full-time, 12-month salaries are not currently paid
to comparable staff members, the salary proposed must be appropriately
related to the existing salary structure. Confirmation of salary may be
required prior to the issuance of an award. Fringe benefits, based on the
sponsoring institution’s rate and the percent of effort, are provided in
addition to the salary.

The sponsoring institution may
supplement the NIH salary contribution up to a level that is consistent with
the institution's salary scale. Institutional supplementation of salary must
not require extra duties or responsibilities that would interfere with the
purpose of the K24 award.

In addition, the candidate may
derive additional compensation for effort associated with other Federal
sources or awards provided the total salary derived from all Federal sources
does not exceed the maximum legislated salary rate and the total percent
effort does not exceed 100%.

Other Program-Related Expenses

The NIH will provide up to $50,000 per year for the
following expenses: (a) research expenses, such as supplies, equipment and
technical personnel for the PD/PI and the mentees; (b) travel to research
meetings or training; (c) statistical services including personnel and
computer time.

Salary for secretarial and administrative assistance,
etc., is not allowed.

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs.

NIH grants policies as
described in the NIH Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions:

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher Education Institutions
are always encouraged to apply for NIH support as Public or Private
Institutions of Higher Education:

Non-domestic (non-U.S.) Entities (Foreign Organizations) are
not eligible to apply. Foreign (non-U.S.) components of U.S. Organizations are not allowed.

Required Registrations

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Directors/Principal Investigators (PD/PIs) must
also work with their institutional officials to register with the eRA Commons
or ensure their existing eRA Commons account is affiliated with the eRA Commons
account of the applicant organization.

All registrations must be completed by the application due
date. Applicant organizations are strongly encouraged to start the registration
process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal
Investigator)

Any candidate with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director/Principal
Investigator (PD/PI) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented
racial and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support. Multiple Principal Investigators are not
allowed.

By the time of award, the individual must be a citizen or a
non-citizen national of the United States or have been lawfully admitted for
permanent residence (i.e., possess a currently valid Permanent Resident Card
USCIS Form I-551, or other legal verification of such status). Individuals on temporary or student visas are not eligible.

Candidates for this award must have a health-professional
doctoral degree or its equivalent. Such degrees include but are not limited to
the M.D., D.O., D.D.S., D.M.D., O.D., D.C., Pharm.D., N.D. (Doctor of
Naturopathy), as well as a doctoral degree in nursing. Candidates with Ph.D.
degrees are eligible for this award if the degree is in a clinical field or
they perform patient-oriented research (POR). This may include clinical
psychologists, clinical geneticists, speech and language pathologists.

Candidates should typically be in the midcareer stage at the
Associate Professor level or functioning at that rank in an academic setting or
equivalent non-academic setting and must have an established record of
independent, peer-reviewed patient-oriented research grant funding including at
the time of application and record of publications. This award is intended for
individuals who have a record of supervising and mentoring patient-oriented
researchers. A K24 award recipient who is promoted to Full Professor, but
continues to have an independent peer-reviewed patient-oriented research
program and provides mentoring to new investigators, may continue to be
supported through the K24 program..

Applicant organizations may submit more than one application,
provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the
same as one already reviewed. An individual may not have two or more competing
NIH career development applications pending review concurrently. Resubmission applications may be submitted, according to the NIH Policy on Resubmission
Applications from the SF 424 (R&R) Application Guide.

Level of Effort

Candidates must be able to demonstrate the need for
protected time, 3-6 person months (25-50% of full-time professional effort) for
a period of intensive research focus as a means of augmenting their
capabilities in POR and act as a mentor to new clinical investigators in the
conduct of POR during this period. Candidates for the K24 award may not have
pending peer review or concurrently apply for any other PHS career award.

Renewals

Depending on the policies of the awarding IC, K24 awardees
may apply for a one-time renewal for an additional three to five years of
support if the K24 recipient continues to have independent peer-reviewed
research support at the time of submission of the renewal application.
Candidates should clearly demonstrate their continuing need for protected time
to expand their research programs and to serve as mentors to more junior POR
researchers.

Peer Reviewed Research
Support

Depending on the policies of the sponsoring IC, candidates
are expected to continue to hold independent peer-reviewed research support for
the period of this award. Candidates losing this support during the award
period must document in their annual Progress Reports efforts to replace this
support and demonstrate that they continue to meet all other requirements of
the K24 award.

Institutional Environment

The institution must be able to demonstrate a commitment to
the candidate as a productive, independent investigator. The application must
describe a program that will use the relevant research and educational
resources and facilities available. The institution must certify that the
candidate will be released from other duties and be able to devote between 3-6 person-months (25 to 50% full-time
professional effort) to a patient-oriented research program. The applicant
institution must document the availability of beginning clinical investigators
(including junior clinical faculty) to be mentored. In addition, if there is an
NIH institutional career development award (K12); an NIH Clinical Translational
Science Award (CTSA) with an institutional career development component; or an
NIH Clinical Research Curriculum Award (K30) at the sponsoring institution, a
plan should be described for integrating the proposed K24 mentoring activities
with activities under these programs.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not be accepted for
review.

Required and Optional Components

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the general
application package are required for submission
of an application for a career development award. Follow the
instructions in the SF 424 (R&R) to determine which components are
required.

Page Limitations

All page limitations described in the SF424 (R&R)
Application Guide and the Table of Page Limits must be followed.

PHS 398 Career Development Award Supplemental Form

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Candidate’s Background (Component of
Candidate Information)

Provide details of the candidate’s immediate and long-term career
objectives in POR and in mentoring new clinician investigators.

Include a summary of the research career of the candidate,
documenting the ability of the candidate to conduct high quality POR and
commitment to a career in POR.

Document the ability of the K24 candidate to provide mentoring to
new clinician investigators. Provide the number of years of mentoring
experience, mentoring role (i.e., research advisor, clinical mentor, etc.), the
number of clinicians mentored, the specialties of the individual mentees and the
stages in their professional career. In addition, describe the types of
research that were conducted by the individuals mentored, and the proportion of
mentored individuals currently in academic medicine and/or directly
participating in POR.

Provide an explanation as to how relief from patient care or
administrative responsibilities through the protected time provided by this
award will contribute to the development or expansion of the candidate’s POR
program and increased level of commitment to mentoring beginning clinician
investigators. It is important to convey to the reviewers the reasons for
needing protected time to continue a vital research program and continue to
engage in the mentoring of new scientists. It should be clear that this award
will permit the candidate to spend more time on research and mentoring and less
time on administrative and clinical responsibilities for the institution.

Career Goals and Objectives
(Component of Candidate Information)

Describe the candidate’s career goals and objectives under this
award, including prior experience, and current research support. Candidates are
encouraged to provide a timeline for accomplishing these goals.

Career Development/Training
Activities During Award Period (Component of Candidate Information)

Describe the professional responsibilities/activities including
other research projects beyond the minimum required effort commitment to the
career award. Explain how these responsibilities/activities will help ensure
career progression to achieve independence as an investigator.

The candidate should describe any new or enhanced research skills
and knowledge he/she will acquire during the career award period, and how these
skills and experiences will significantly enhance his/her ability to continue
his/her research programs as independent scientists.

Training in the Responsible Conduct of Research

Applications must include a description of a plan to provide
instruction in responsible conduct of research.

This section should document the nature of the applicant’s prior
participation in responsible conduct of research instruction (lecturer,
discussion leader, etc.), including the date of last occurrence and propose
plans to participate in instruction in responsible conduct of research.

Such plans must address four instructional components, format,
subject matter, duration of participation, and frequency of participation, as
outlined and explained in NOT-OD-10-019.

The plan may include career stage-appropriate, independent
scholarly activities that will enhance the applicant’s understanding of ethical
issues related to their specific research activities and the societal impact of
that research.

Applications lacking a plan for participation in responsible
conduct of research will be considered incomplete and may be delayed in the
review process or may not be reviewed

The background, rationale and more detail about instruction in
the responsible conduct of research can be found in NOT-OD-10-019.

Mentoring Plan (Component of
Candidate Information)

This is a required component of the K24 application. The plan to provide mentoring should
include a description of the availability of new clinician investigators for mentoring;
their previous training and specialization; plans for recruitment, selection
and supervision; the types of educational and research experiences that will be
provided; and the capacity in which the candidate for the K24 award will serve
as a mentor. If there is an existing clinical research curriculum (e.g. an NIH
K30) or a Clinical Translational Science Center (CTSA), describe how the
mentoring plan will be integrated with the curriculum. Candidates must also
describe a plan for supporting the research of their mentees during the period
of the K24 award. This plan should include active support for POR at the time
of application for a K24 Award, and may include K24 Research Development
Support. Candidates must indicate the proposed person-months (percent effort)
committed to the mentoring plan.

Statements by Consultants,
Contributors (Component of Statements of Support)

Signed statements must be provided by each consultant/collaborator
confirming their participation in the project and describing their specific
roles. Collaborators and consultants generally do not need to provide their
biographical sketches. However, information should be provided that clearly
documents expertise in the proposed area(s) of consulting/collaboration.

Description of Institutional
Environment (Component of Environment and Institutional Commitment to the
Candidate)

The sponsoring institution must define and document a
well-established research program related to the candidate's area of interest
including a high-quality research environment with staff capable of productive
collaboration with the candidate.

Include a description of the facilities and other resources that
will be provided to the candidate.

Descriptions of the institution should be sufficiently detailed
so that reviewers can determine if the environment is conducive to performing
high quality POR. This information will be evaluated very carefully by the peer
reviewers and carry substantial weight in the evaluation of an application.

Institutional Commitment to the
Candidate’s Research Career Development (Component of Environment and
Institutional Commitment to the Candidate)

The sponsoring institution must provide a letter of commitment to
the candidate's career goals as a productive, independent investigator and to
meeting the requirements of this award. It should be clear that the
institutional commitment to the candidate is not contingent upon receipt of the
K24 award.

The letter of commitment from the institution should provide
statements concerning the amount of protected time the candidate will receive (3-6 person-months or 25 to 50% full-time
professional effort required); the duties from which he/she will be relieved
(if clinical duties the institution should describe specific steps that will be
taken to cover these duties, such as hiring clinical staff); and the
institutional commitment to enhancing the candidate's ability to be a
productive, independent investigator.

Provide assurance that the candidate is an integral part of the
institution’s research and academic program.

Research Strategy (Component of
Research Plan)

A sound research project that is consistent with the candidate’s
level of research development and objectives of his/her career development plan
must be provided. The research description should demonstrate not only the
quality of the candidate’s research thus far but also the novelty,
significance, creativity and approach, as well as the ability of the candidate
to carry out the research.

Currently
supported research: There is no need to provide extensive detail
with regard to ongoing, funded research. Enough information should, however, be
provided in the areas of Hypotheses and Specific Aims; Background, Significance
and Rationale; Preliminary Studies and Results; and Research Design and Methods
to permit the peer reviewers to evaluate the extent, special features and
general quality of the candidate's research activities and opportunities for
mentoring.

New
research to be specifically supported by this award: Describe how
this award will be used to help augment the candidate’s research skills and/or
develop new directions in POR. This description should include a Statement of
Hypothesis and Specific Aims; Background, Preliminary Studies and Aims;
Significance and Rationale; and Research Design and Methods. Although it is not
expected that this description would be as detailed as an application for an
investigator-initiated research grant (e.g., R01), it is expected that
sufficient detail be provided to permit an evaluation of the scientific merit
of the research, and to clearly show research opportunities for mentoring.
Documentation must be provided that appropriate and adequate resources, both in
terms of support and facilities, are available to the candidate to conduct the
research program(s). This is an important part of the application because it
will provide the main rationale and justification needing protected time for
research. The candidate must ensure that the inclusion of women, members of
minority groups and their subpopulations, and children, has been addressed in
the development of the design for all proposed patient-oriented research. The
candidate must provide for each new research project proposed the information
described in the PHS 398 Career Development Award Supplemental form Part 1,
Section 7 of the R&R 424 instructions. Candidates must provide plans for
ensuring continuing support of their POR programs preferably with them as the
PD/PI.

Appendix

Do not use the appendix to circumvent page limits.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

3. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.

Applicants are
responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of on-time submission are
provided in the SF424 (R&R) Application Guide.

For assistance with your electronic application or for
more information on the electronic submission process, visit Applying
Electronically.

Important reminders:All PD/PIs must include their eRA Commons ID in the Credential fieldof
the Senior/Key Person Profile Component of the SF 424(R&R) Application
Package. Failure to register in the Commons and to include a valid PD/PI
Commons ID in the credential field will prevent the successful submission of an
electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the Central Contractor Registration (CCR). Additional
information may be found in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for
post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1.
Criteria

Only the
review criteria described below will be considered in the review process. As
part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers should provide their assessment of the likelihood
for the candidate to maintain a strong research program, taking into
consideration the criteria below in determining the overall impact/priority
score.

Scored Review Criteria

Reviewers will consider each of the review criteria below in
the determination of scientific merit, and give a separate score for each. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Candidate

Is there evidence of ongoing high quality patient-oriented
research, and what is the relationship of that research to this K24 application?

Is there evidence of the candidate's capabilities and commitment to
serve as a mentor for new clinical investigators in the conduct of
patient-oriented research?

Does the application demonstrate that the proposed program and
protected time will relieve the candidate from non-research patient care and
administrative duties and allow him/her to devote additional time and to
augment his/her capabilities in patient-oriented research?

Does the application demonstrate a record of independent
peer-reviewed support for patient-oriented research that is likely to continue
during the K24 award?

Plan to Provide Mentoring

Are the plans to provide mentoring or supervising new clinical
investigators in patient oriented research adequate?

Are plans to integrate appropriate clinical research curricula,
such as those offered by available K30 programs at the institution, into the
mentoring plans adequate?

Is an appropriate level of effort proposed for the mentoring
component?

Research Plan

Candidates are expected to have an independent, peer reviewed
research support at the time the career award is made. In such instances,
reviewers should not re-evaluate the research plan. Rather, the reviewers
should evaluate how the research and career development plans together further
the candidate’s research career.

Is the research plan an appropriate vehicle for demonstrating and
developing the prospective mentee’s skills and capabilities in patient-oriented
research?

Are the scientific and technical plans of the proposed research
of merit?

Is the proposed research relevant to the candidate's career
objectives?

Are adequate resources available to conduct the research program?
This includes adequacy of plans for continued support of the research during
the funding period of the grant.

Consultant(s), Collaborator(s)

Is there adequate information provided that clearly documents
expertise in the proposed area(s) of consulting/collaboration?

Environment & Institutional
Commitment to the Candidate

Is the level of the applicant institution’s commitment to the
scientific development of the candidate appropriate?

Is the level of assurance from the institution that they intend
the candidate to be an integral part of its patient-oriented research program
adequate?

Are the research facilities, resources and appropriate
educational opportunities available to the candidate appropriate and adequate?

Are the size and quality of the pool of clinician investigators
to be mentored by the PI/PD adequate?

Are the quality and relevance of the environment for continuing
the scientific and professional development of the candidate and for others
pursuing patient-oriented research appropriate and adequate?

Is there adequate commitment from the sponsoring institution to
provide protected time for the candidate to conduct the research and mentoring
program?

Is the level of commitment of the candidate’s institution to the
career development in patient-oriented research of new clinical investigators
mentored by the candidate adequate?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact/priority score, but will
not give separate scores for these items.

Protections for Human Subjects

For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their participation
according to the following five review criteria: 1) risk to subjects, 2)
adequacy of protection against risks, 3) potential benefits to the subjects and
others, 4) importance of the knowledge to be gained, and 5) data and safety
monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46, the
committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and
Children

When the proposed project involves clinical research,
the committee will evaluate the proposed plans for inclusion of minorities and
members of both genders, as well as the inclusion of children. For additional
information on review of the Inclusion section, please refer to the Human
Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live
vertebrate animals as part of the scientific assessment according to the
following five points: 1) proposed use of the animals, and species, strains,
ages, sex, and numbers to be used; 2) justifications for the use of animals and
for the appropriateness of the species and numbers proposed; 3) adequacy of
veterinary care; 4) procedures for limiting discomfort, distress, pain and
injury to that which is unavoidable in the conduct of scientifically sound
research including the use of analgesic, anesthetic, and tranquilizing drugs
and/or comfortable restraining devices; and 5) methods of euthanasia and reason
for selection if not consistent with the AVMA Guidelines on Euthanasia. For
additional information on review of the Vertebrate Animals section, please
refer to the Worksheet
for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures
proposed are potentially hazardous to research personnel and/or the
environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For Renewals, the committee will consider the
progress made in the last funding period.

Revisions

For Revisions, the committee will consider the
appropriateness of the proposed expansion of the scope of the project. If the
Revision application relates to a specific line of investigation presented in
the original application that was not recommended for approval by the committee,
then the committee will consider whether the responses to comments from the
previous scientific review group are adequate and whether substantial changes
are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Training in the Responsible Conduct
of Research

Taking into account the circumstances of the
candidate, including the more senior level of experience of candidates for this
award, the reviewers will address the following questions: Does the plan
satisfactorily address the format of instruction, e.g. lectures, coursework,
and/or real-time discussion groups that the candidate will participate in? Do
plans include a sufficiently broad selection of subject matter, such as
conflict of interest, authorship, data management, human subjects and animal
use, laboratory safety? Do the plans adequately describe the candidate’s role
in the participation in instruction in RCR? Does the plan meet the minimum
requirements for RCR, i.e., eight contact hours of instruction every four
years? Plans and past record will be rated as acceptable or unacceptable,
and the summary statement will provide the consensus of the review committee.

Select Agent Research

Reviewers will assess the information provided in
this section of the application, including 1) the Select Agent(s) to be used in
the proposed research, 2) the registration status of all entities where Select
Agent(s) will be used, 3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety,
biocontainment, and security of the Select Agent(s).

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review), will be discussed and assigned an overall impact/priority
score.

Will receive a written critique.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons.

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program. Accordingly, recipients are hereby notified that
they may be contacted after the completion of this award for periodic updates
on various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

A final progress report, invention statement, and Financial
Status Report are required when an award is relinquished when a recipient
changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of applicable
NIH grants and cooperative agreements are required to report to the
Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants
Policy Statement for additional information on this reporting requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and
welcome the opportunity to answer questions from potential applicants.

Special Note: Applicants are cautioned that not all NIH Institutes and
Centers (ICs) participate in this program, and that consultation with relevant
IC staff prior to submission of an application is strongly encouraged. The
participating ICs have different emphases and program requirements for this
program. Therefore, a prospective applicant is urged to consult the Table of
IC-Specific Information, Requirements and Staff Contacts to
determine whether the planned research and training falls within the mission of
one of the participating NIH ICs.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.